Exports and Imports


FDA Export Certificates

Guidance for Industry - FDA Export Certificates


FDA Regulatory Procedures Manual Section on Imports and Exports

CDER Export Certificate Program Frequently Asked Questions (FAQs) http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/importsandexportscompliance/ucm388842.pdf

Webinar of August 8, 2012 titled "CDER Export Compliance and the Certificate of a Pharmaceutical Product (CPP) Application Process". The FDA provided a http://www.fda.gov/drugs/developmentapprovalprocess/smallbusinessassistance/ucm313319.htm. The webinar discussed the regulatory history of exports, current regulations and the Certificate of a Pharmaceutical Product (CPP). that contained a lot of information about what is required.